Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery

Major Abdominal Surgery Clinical Trial

Official title:

Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery in Non-obese American Soceity of Anesthesiologists (ASA) 1-3 Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01403909
• Other study ID #: LOCAL/2011/DC-04
• Secondary ID: 2011-A00800-41
• Status: Withdrawn
• Phase: N/A
• First received: July 26, 2011
• Last updated: March 24, 2015
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must have given his/her informed and signed consent

• The patient must be insured or beneficiary of a health insurance plan

• Patient with ASA score 1-3

• Body mass index < 30 kg/m^2

• Patient is schelduled for major abdominal surgery (laparotomy without risk of haemorrhage whose duration is assumed to be greater than 120 min)

• The patient passes from home, directly to the hospital, without schelduled hospitalization in another department

Exclusion Criteria:

• The patient is participating in another study

• The patient is in an exclusion period determined by a previous study

• The patient is under judicial protection, under tutorship or curatorship

• The patient refuses to sign the consent

• It is impossible to correctly inform the patient

• The patient is pregnant

• The patient is breastfeeding

• The patient has a contra-indication for treatment necessary for the study

• ASA score > 3

• body mass index > 30 kg/m^2

• Expected surgical time of < 120 minutes

• Surgery with risk of hemorrhage

• Surgery via celioscopy

• The surgery require perineal access, thus rendering any blinding impossible

• Hepatic surgery

• Contra indication for intermittent venous compression

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Major Abdominal Surgery

Intervention

Device:
• Intermittent pneumatic compression
Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery.

Procedure:
• Standard care
Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume fluids (ml)	The total volume of infused fluids (Ringer's Lactate and HES) delivered to the patient during surgery (ml)	End of surgery (expected mean of 2 hours)	No
Secondary	Hypotensive episodes	The number of arterial hypotension episodes (systolic pressure < 90 mmHg)	end of surgery (expected mean of 2 hours)	Yes
Secondary	VEGF	Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood	end of surgery (expected mean of 2 hours)	No
Secondary	sFlt1	Concentration (pg/ml) of soluble vascular endothelial growth factor receptor-1 (sFlt1) in blood	end of surgery (expected mean of 2 hours)	No
Secondary	Hematocrit %		end of surgery (expected mean of 2 hours)	No
Secondary	Albumin	Albuminemia (g/l)	end of surgery (expected mean of 2 hours)	No
Secondary	Prothrombin (%)	Prothrombin rate in blood	end of surgery (expected mean of 2 hours)	No
Secondary	Activated partial thromboplastin time	Activated partial thromboplastin time (seconds)	end of surgery (expected mean of 2 hours)	No
Secondary	Presence/absence of POSSUM complications	Presence/absence of complications as defined by the Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (POSSUM) criteria	28 days	Yes
Secondary	Days of hospitalization	Length of hospitalization (days)	28 days	No
Secondary	Number of days not in hospital	Number of days not in hospital	28 days	No